Important Data After Drug Approval: Comment on “Dabigatran Association With Higher Risk of Acute Coronary Events”

Extract

Continued data collection and analysis allow us to learn important additional information about new drugs after US Food and Drug Administration approval. In the case of dabigatran, we have recently learned that the lack of ability to monitor the bleeding level and serious bleeding episodes associated with deaths have led to safety warnings in Australia and Japan and a renal assessment advisory by the European Medicines Agency. The lack of a reversal agent has been associated with deaths among trauma victims who are receiving dabigatran. A recent Medco Health Solutions report found that the actual stroke and bleeding rates found at 4 months for dabigatran were equivalent to or higher than the stroke and bleeding rates per year for warfarin from the RE-LY trial. Now, Uchino and Hernandez highlight an additional serious concern for dabigatran—an increased relative risk of 27% to 33% of MI and ACS. These additional concerns deserve serious consideration in weighing the risks and benefits of dabigatran and highlight the importance of continued collection and analysis of data after drug approval.

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